DESCRIPTION (provided by applicant):The goal of this proposal is to establish
the value of the 3' noncoding region (NTR) of hepatitis C virus ((HCV genome as
an amplification target in a viral load assay. HCV is the most prevalent
chronic bloodborne infection in the U.S. Although the number of new infections
has declined substantially, there are still an estimated 36,000 new infections
each year and approximately 1.8 percent of the U.S. population (3.9 million) is
chronically infected. As much as 40 percent of chronic liver disease is HCV
related and this results in up to 10,000 deaths each year. The presence of
anti-HCV antibody does not distinguish between acute, chronic, or resolved
infection nor can anti-HCV antibody levels be used to monitor disease
progression or therapeutic efficacy. Quantitative measurement of HCV RNA levels
in serum has been successfully used to predict response to therapy. Several
qualitative and quantitative HCV RNA assays have been developed, but none is
without technical problems and none has yet received FDA approval. Optimal
management of HCV infections and further progress toward understanding HCV
pathogenesis will depend on ongoing efforts to maximize the performance of HCV
RNA load assays. This proposal targets a unique region of the genome which may
be critical to achieving this goal.
PROPOSED COMMERCIAL APPLICATIONS:
Measurement of the level of HCV RNA in serum is becoming an increasingly important component of the management of patients who are chronically infected with HCV. Optimal management of HCV infections will depend on continued efforts to maximize the performance of HCV RNA load assays. If the 3'NTR proves to be the optimal genomic target for measuring HCV RNA, the work proposed here will be directly applied to a commercially and clinically valuable HCV viral load test.